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Tube, Bronchial (W/Wo Connector)

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Tube, Bronchial (W/Wo Connector)

The FDA MAUDE database aggregates 2,398 adverse-event reports for Tube, Bronchial (W/Wo Connector) spanning the period from 1992 through 2026. Of these, 5 are classified as death reports, 167 as injury reports, and 2,222 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 12 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Use of Device Problem topping the list at 369 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 28 years of MAUDE data, with the peak single-year volume reaching 312 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 5 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

2,398
Total Reports
5
Death Reports
167
Injury Reports
2,222
Malfunctions

Event Types

Malfunction 2,222 (92.7%)
Injury 167 (7.0%)
Death 5 (0.2%)
3 (0.1%)
Other 1 (0.0%)

Patient Outcomes

2,169 (90.6%)
Required Intervention 172 (7.2%)
Other 22 (0.9%)
R 10 (0.4%)
Hospitalization 5 (0.2%)
H 3 (0.1%)
L 3 (0.1%)
Death 3 (0.1%)
Life Threatening 3 (0.1%)
D 2 (0.1%)
O 2 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Use of Device Problem 369
Gas/Air Leak 356
Deflation Problem 268
Inflation Problem 124
Leak/Splash 119
Material Split, Cut or Torn 73
Defective Component 34
Break 33
Human-Device Interface Problem 20
Material Separation 18
Partial Blockage 18
Fluid/Blood Leak 14
Insufficient Information 14
Material Integrity Problem 14
Material Rupture 14
Detachment of Device or Device Component 13
Air Leak 12
Appropriate Term/Code Not Available 12
Obstruction of Flow 11
Disconnection 10

Yearly Trend

92
1992: 3
94
1994: 2
97
1997: 4
00
2000: 2
01
2001: 1
02
2002: 1
03
2003: 2
04
2004: 2
06
2006: 2
07
2007: 1
09
2009: 2
10
2010: 24
11
2011: 29
12
2012: 89
13
2013: 116
14
2014: 228
15
2015: 312
16
2016: 226
17
2017: 190
18
2018: 124
19
2019: 122
20
2020: 91
21
2021: 110
22
2022: 140
23
2023: 162
24
2024: 172
25
2025: 207
26
2026: 34

Related Entities for Tube, Bronchial (W/Wo Connector)

Event Locations

1,340 (55.9%)
I 1,039 (43.3%)
HOSPITAL 16 (0.7%)
NO INFORMATION 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare MALLINCKRODT MEDICAL vs TELEFLEX MEDICAL →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.